Clinical and radiographic effects of TiUltra after prosthetic restoration (On1 concept) - a practice-based observational study

• Conditions: Z96.5; Presence of tooth-root and mandibular implants

• Registration Number: DRKS00033650
• Lead Sponsor: Dr. Mohammad Albarazi MSc Zahnordinationen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion criteria
- Mentally healthy adults, i.e. patients capable of giving informed consent
- Good general health (ASA = 2 )
a.Diabetes mellitus should be well controlled (HbA1c < 7 )
b.Smoking = 20 cigarettes / day
c.No alcohol or drug abuse
- No pathology of the bone metabolism
- Patients with periodontitis should be successfully treated, i.e. as far as possible no remaining periodontal infection.
- Good oral hygiene and compliance, i.e. plaque level (full-mouth plaque score, FMPS) < 25% and bleeding level after probing (full-mouth bleeding on probing score, FMBS) < 25%
- A 3D radiological bone volume (possibly after augmentation procedures such as sinus lift) must be available for insertion of the planned implants.
- Patient and anatomical conditions must correspond to the instructions for use of the implants to be used (NobelParallelTM Conical Connection, TiUltraTM surface).
- Edentulous areas must be suitable for the intended implant-supported restoration.
- Sufficiently keratinised peri-implant mucosa.
- Tooth removal should generally have taken place three months previously.
- Existing opposing dentition
- Patients must be prepared to adhere to a prevention concept (supportive therapy, UT). This is a routine protocol.
- Written informed consent for participation in this study

Exclusion Criteria

Exclusion criteria
- Minors
- Pregnant and breastfeeding patients
- Taking antiresorptives
- Patients with a known titanium allergy
- Patients with temporomandibular joint dysfunction (TMD, TMJD)

Study & Design

• Study Type: observational
• Study Design: Not specified